活血化瘀中药及复方治疗急性脑出血的Meta分析

Meta-analysis of acute intracerebral hemorrhage treated with traditional Chinese medicine or/and composition of promoting blood circulation and removing blood stasis

目的 :根据循证医学的方法 ,对活血化瘀中药治疗急性脑出血的临床研究进行系统评价和Meta分析 ,以期对活血化瘀中药治疗急性脑出血的疗效作出客观、可信的评价。方法 :全面收集活血化瘀中药及复方的治疗急性脑出血的临床试验 ,在严格质量评价的基础上 ,利用RevMan 4.1软件进行Meta分析 ;对纳入的文献进行活血化瘀中药的筛选。结果 :共 2 1篇文献符合纳入标准。包括随机对照试验 17篇 ,2篇使用了盲法 ;临床对照试验 4篇。文献的质量属于JADAD分级C或D。经Meta分析 ,治疗后的死亡率在活血化瘀中药及复方组 (治疗组 )和对照组中分别为 10 6 % (74/ 70 1)和 2 5 7% (15 6 / 6 0 7) ,(P <0 .0 1)。治疗组的病死、严重致残率明显低于对照组 ,分别为 41 3 % (5 12 / 12 39)和 6 5 9% (6 75 / 10 2 4) ,(P <0 .0 1)。结论 :活血化瘀疗法治疗急性脑出血可能有效 ,有降低脑出血患者病死、严重致残率的趋势 ;大黄、水蛭和三七是治疗急性脑出血的主要药物。应按照国际中风研究的标准设计临床方案 ,进行严格的、多中心、大样本的随机双盲对照试验 ,以提供更具说服力的证据。

Objective:To systematically assess the efficacy and safety of drugs promoting blood circulation and removing blood stasis(PBC&RBS)based on strict quality evaluation of reports of clinical study.Methods:All the papers of clinical studies that used PBC & RBS as the main intervention to manage ICH were retrieved and collected and random effect model of Meta analysis was performed by using the statistical software RevMan 4.1 on the basis of strick quality evalution. Sensitivity analysis was carried out between various inclusion criteria.The most popular PBC & RBS TCM were selected.Results:21 papers were included,of which there were 17 randomized controlled trial(RCT),4 clinical controlled trial(CCT);blinding method was used only in 2 studies.All 21 papers were C or D under JADAD measurment.Meta analysis suggested a benefit from PBC&RBS, with a reduction in the chance of death ( P <0.01) and death+disability ( P <0.01) after treated with (TCM)or/and Composition of PBC & RBS. Conclusion:Rheum,leech and Panax notoginseng is the most popular TCM used in treating ICH.The evidence of a large,multicenter,randomized controlled trial are urgently needed.